96 drugs lost exclusivity in 2022

In 2022, the FDA approved 96 first-time generic drugs. 

Here's the list of the generics and their treatment use, in order of approval date: 

Note: Repeats are abbreviated new drug applications from different drugmakers.

  1. Pirfenidone capsules — For the treatment of idiopathic pulmonary fibrosis
  2. Carbidopa, levodopa and entacapone tablets — For the treatment of Parkinson's disease
  3. Pirfenidone tablets — For the treatment of idiopathic pulmonary fibrosis
  4. Pirfenidone tablets — For the treatment of idiopathic pulmonary fibrosis
  5. Sofosbuvir tablets — For the treatment of adult patients with genotype 1, 2, 3 or 4 chronic HCV infection without cirrhosis or with compensated cirrhosis as a component of a combination antiviral treatment regimen
  6. Dextroamphetamine saccharate, amphetamine aspartate monohydrate, dextroamphetamine sulfate, amphetamine sulfate extended release capsules — For the treatment of attention-deficit hyperactivity disorder in patients 13 years and older
  7. Brimonidine tartrate ophthalmic solution, 0.15% — For the reduction of elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension
  8. Cyclosporine ophthalmic emulsion, 0.05% — To increase tear production in patients whose tear production is presumed to be suppressed due to ocular inflammation associated with keratoconjunctivitis sicca
  9. Maraviroc tablets — For the treatment of only CCR5-tropic HIV-1 infection in adults and pediatric patients weighing at least 2 kg
  10. Digoxin tablets — For the treatment of mild to moderate heart failure in adults
  11. Nalmefene hydrochloride injection — For the complete or partial reversal of opioid drug effects, including respiratory depression, induced by either natural or synthetic opioids; for management of known or suspected opioid overdose
  12. Tolvaptan tablets — Treatment of clinically significant hypervolemic and euvolemic hyponatremia including patients with heart failure and Syndrome of Inappropriate Antidiuretic Hormone
  13. Dapagliflozin tablets — As an adjunct to diet and exercise to improve glycemic control
  14. Apomorphine hydrochloride injection, single-patient-use glass cartridge for use with a reusable pen injector — For the acute, intermittent treatment of hypomobility, "off" episodes associated with advanced Parkinson's disease
  15. Doxylamine succinate and pyridoxine hydrochloride extended release tablets — For the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management
  16. Methylphenidate transdermal system — For the treatment of attention-deficit/hyperactivity disorder (ADHD)
  17. Breyna (budesonide and formoterol fumarate dihydrate) inhalation aerosol — For the treatment of asthma in patients 6 years and older and for the maintenance treatment of airflow obstruction and reducing exacerbations in patients with chronic obstructive pulmonary disease (COPD) including chronic bronchitis and/or emphysema
  18. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  19. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  20. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  21. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  22. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  23. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  24. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  25. Lacosamide tablets — Treatment of partial-onset seizures in patients 4 years and older
  26. Lactated ringer's and 5% dextrose injection — For the parenteral replacement of extracellular losses of fluid and electrolytes, with or without minimal carbohydrate calories, as required by the clinical condition of the patient
  27. Sodium phosphates injection — As a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake
  28. Brimonidine tartrate and timolol maleate ophthalmic solution — For the reduction of elevated intraocular pressure in patients with ocular hypertension who require adjunctive or replacement therapy due to inadequately controlled IOP
  29. Isosorbide dinitrate and hydralazine hydrochloride tablets — For the treatment of heart failure as an adjunct therapy to standard therapy in self-identified Black patients to improve survival, prolong time to hospitalization for heart failure and to improve patient-reported functional status
  30. Lacosamide injection — For the treatment of partial-onset seizures in patients 17 years and older
  31. Cysteine hydrochloride injection — Indicated to meet the nutritional requirements of newborn infants requiring total parenteral nutrition; and of adult and pediatric patients with severe liver disease who may have impaired enzymatic processes and require TPN
  32. Regadenoson injection — Indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress
  33. Regadenoson injection — Indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress
  34. Regadenoson injection — Indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress
  35. Regadenoson injection — Indicated for radionuclide myocardial perfusion imaging in patients unable to undergo adequate exercise stress
  36. Phytonadione injectable emulsion — For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity
  37. Phytonadione injectable emulsion — For the treatment of certain coagulation disorders which are due to faulty formation of factors II, VII, IX and X when caused by vitamin K deficiency or interference with vitamin K activity
  38. Bexarotene Gel — For the topical treatment of cutaneous lesions in patients with CTCL (Stage IA and IB) who have refractory or persistent disease after other therapies or who have not tolerated other therapies
  39. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  40. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  41. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  42. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  43. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  44. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  45. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  46. Bortezomib for injection — For the treatment of adult patients with multiple myeloma; treatment of adult patients with mantle cell lymphoma
  47. Zinc sulfate injection — As a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient or contraindicated
  48. Diclofenac topical solution — For the treatment of the pain of osteoarthritis of the knee
  49. Mesalamine extended release capsules — For the induction of remission and for the treatment of adult patients with mildly to moderately active ulcerative colitis
  50. Estradiol and progesterone capsules — For the treatment of moderate to severe vasomotor symptoms due to menopause
  51. Lacosamide oral solution — For the treatment of partial-onset seizures in patients 4 years and older
  52. Iodixanol injection — Radiographic contrast agent indicated for certain intra-arterial and intravenous procedures
  53. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  54. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  55. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  56. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  57. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  58. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  59. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  60. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  61. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  62. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  63. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  64. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  65. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  66. Pemetrexed for injection — For the treatment of non-squamous non-small cell lung cancer and mesothelioma
  67. Posaconazole injection — For the prophylaxis of invasive Aspergillus and Candida infections in patients who are at high risk of developing these infections due to being severely immunocompromised
  68. Atropine Sulfate injection — For the temporary blockade of severe or life threatening muscarinic effects
  69. Multiple Electrolytes injection — Indicated as a source of water and electrolytes or as an alkalinizing agent
  70. Brivaracetam tablets — For the treatment of partial-onset seizures in patients 4 years and older
  71. Ibuprofen oral suspension (OTC) — For the temporary reduction of fever, relief minor aches and pains due to the common cold, flu, headaches and toothaches
  72. Cabazitaxel injection — In combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen
  73. Abiraterone acetate tablets — In combination with methylprednisolone for the treatment of patients with metastatic castration-resistant prostate cancer
  74. Multiple electrolytes injection — Indicated as a source of water and electrolytes or as an alkalinizing agent
  75. Empagliflozin and metformin hydrochloride tablets — As an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus; to reduce the risk of cardiovascular death in adults with Type 2 diabetes mellitus and established cardiovascular disease
  76. Fenoprofen calcium capsules — For the relief of mild to moderate pain in adults; relief of the signs and symptoms of rheumatoid arthritis; relief of the signs and symptoms of osteoarthritis
  77. Sodium picosulfate, magnesium oxide, and anhydrous citric acid for oral solution — For the cleansing of the colon as a preparation for colonoscopy in adults and pediatric patients ages 9 years and older
  78. Pirfenidone tablets — For the treatment of idiopathic pulmonary fibrosis
  79. Azilsartan medoxomil tablets — For the treatment of hypertension to lower blood pressure
  80. Minocycline for injection — For the treatment of infections caused by certain Gram-negative and Gram-positive bacteria, and others, when bacteriologic testing indicates appropriate susceptibility
  81. Empagliflozin tablets — Indicated as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes mellitus
  82. Estradiol Gel, 0.1% — For the treatment of moderate to severe vasomotor symptoms due to menopause
  83. Brexpiprazole tablets — For use as an adjunctive therapy to antidepressants for the treatment of major depressive disorder in adults; treatment of schizophrenia in adults
  84. Cetrorelix acetate for injection — For the inhibition of premature LH surges in women undergoing controlled ovarian stimulation
  85. Rufinamide tablets — For the adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome in pediatric patients 1 year and older and in adults
  86. Sodium nitroprusside in 0.9% sodium chloride injection — For the immediate reduction of blood pressure; for producing controlled hypotension to reduce bleeding during surgery; for the treatment of acute heart failure to reduce left ventricular end-diastolic pressure, pulmonary capillary wedge pressure, peripheral vascular resistance and mean arterial blood pressure
  87. Riociguat tablets — For the treatment of adults with persistent/recurrent Chronic Thromboembolic Pulmonary Hypertension after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class; for the treatment of pulmonary arterial hypertension to improve exercise capacity, improve WHO functional class and to delay clinical worsening
  88. Roflumilast tablets — A treatment to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations
  89. Cariprazine capsules — For the treatment of schizophrenia in adults; for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults;for the treatment of depressive episodes associated with bipolar I disorder (bipolar depression) in adults
  90. Tazarotene gel, 0.05% — For the topical treatment of plaque psoriasis of up to 20% body surface area involvement
  91. Tazarotene gel, 0.1% — For the topical treatment of plaque psoriasis of up to 20% body surface area involvement; for the topical treatment of mild to moderate facial acne vulgaris
  92. Vyduo (nebivolol and valsartan) tablets — For the treatment of hypertension, to lower blood pressure
  93. Gefitinib tablets — For the first-line treatment of patients with metastatic non-small cell lung cancer whose tumors have epidermal growth factor receptor exon 19 deletions or exon 21 substitution mutations
  94. Darunavir tablets — For the treatment of HIV-1 infection in adult and pediatric patients 3 years and older
  95. Mirabegron extended release tablets — For the treatment of overactive bladder in adult patients with symptoms of urge urinary incontinence, urgency, and urinary frequency
  96. Cupric chloride injection — For use as a supplement to intravenous solutions given for total parenteral nutrition

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